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  1. SciScore for 10.1101/2022.05.31.22275010: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The study protocol was approved by each hospital’s Ethical Review committee and conducted according to the Declaration of Helsinki and Council for International Organizations of Medical Sciences International ethical guidelines and ICH GCP guidelines.
    IACUC: The study protocol was approved by each hospital’s Ethical Review committee and conducted according to the Declaration of Helsinki and Council for International Organizations of Medical Sciences International ethical guidelines and ICH GCP guidelines.
    Consent: Participants supplied written informed consent at enrolment.
    Sex as a biological variableSelection was to be based on the safety and immunogenicity, and potential impact on supply of the chosen formulation, i.e. dose-sparing. Participants: Eligible participants were male or female adults, ≥ 18 years of age who had previously received two doses of ChAdOx1-S1-S vaccine 6 months (± 4 weeks) before enrolment and were willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
    RandomizationThis phase 2 randomized, controlled, observer-blinded, multi-center study is ongoing at three sites in Brazil: Hospital de Clínicas de Porto Alegre, Hospital Gloria D’or, Rio de Janeiro and Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN), Natal.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The primary immunogenicity endpoint was ELISA antibody titers against SCB-2019 S-protein expressed as geometric mean titers (GMT), geometric mean-fold rise in titers over baseline (GMFR) and seroconversion rates (SCR) on Days 15 and 29 in all participants who received the correct vaccination and had no major protocol deviation reported or suffered a COVID-19 infection prior to blood draw.
    SCB-2019 S-protein
    suggested: None
    GMTs of neutralizing antibodies against prototype strain ELISA GMTs against SCB-2019 S-protein are presented in IU/mL, GMTs of neutralizing antibodies against variants and ACE2 are expressed in reciprocal units.
    ACE2
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This is a small study with several limitations as a consequence, but the trends are confirmation of other observations. Several studies have shown that heterologous booster vaccination can heighten and broaden the immune response compared with homologous booster doses [17–19]. We restricted this study to one priming vaccine, ChAdOx1-S, but results need to be confirmed with other vaccines, particularly mRNA and inactivated vaccines. We only assessed the immune responses out to four weeks after the booster vaccination, and persistence of any improved immune responses following the heterologous and homologous boosters will have to be assessed. Finally, we did not assess the efficacy of the booster immunization; although there were several cases of COVID-19 reported in this small study population it was not designed to include an efficacy assessment which would also require a placebo group. Notably, none of these cases were severe and there were no hospitalizations due to COVID-19. In conclusion, the formulation of 30 μg SCB-2019 adjuvanted with CpG-1018 and alum is safe and well tolerated and as a heterologous booster vaccine in those previously primed with ChAdOx1-S and is immunologically more effective than that same vaccine given as a homologous booster.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT05087368Not yet recruitingImmunogenicity and Safety of Heterologous and Homologous Boo…


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

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